Drainage bag holder shield and method

ABSTRACT

Reusable drainage bag holder shields are disclosed which have a novel generally oval-shaped configuration and are made of flexible molded materials which are resistant to body secretions and will not deform after extended body contact or cleaning to provide a highly effective support for a removable-type drainage bag and afford improved wearer comfort.

United States Patent [191 Frank 1 Oct. 2, 1973 1 DRAINAGE BAG HOLDERSHIELD AND METHOD [76] Inventor: Mathilda C. Frank, 1800 E. 84th Ave.,Denver, Colo. 80229 [22] Filed: May 20, 1971 [21] Appl. No.: 145,386

[52] US. Cl. 128/283 [51] Int. Cl. A6lf 5/44 [58] Field of Search128/283 [56] References Cited UNITED STATES PATENTS 2,524,750 10/1950Bellinger 128/283 3,074,404

1/1963 Robinson 128/283 3,373,745 3/1968 Benfield et a1 128/2833,528,420 9/1970 Nielsen 128/283 3,557,790 1/1971 Hauser 128/2833,618,606 11/1971 Brown et a1. 128/283 Primary Examiner-Charles F.Rosenbaum Attorney-Reilly & Lewis [57] ABSTRACT Reusable drainage bagholder shields are disclosed which have a novel generally oval-shapedconfiguration and are made of flexible molded materials which areresistant to body secretions and will not deform after extended bodycontact or cleaning to provide a highly effective support for aremovable-type drainage bag and afford improved wearer comfort.

9 Claims, 6 Drawing Figures PATENTED 21973 3 762,412

.11 llll lllllhlllLd 'IIIIA 28 INVENTOR M QTH J LDA c. FRANK Jul L'aHY-ATORNEYS DRAINAGE BAG HOLDER SHIELD AND METHOD BACKGROUND OF THEINVENTION 1. Field This invention in general relates to medicalappliances and more particularly tonovel and improved bag holder shieldsfor supporting drainage bags applied to a patient following certainsurgical procedures.

2. Description of the Prior Art Following certain surgical procedures itis necessary to mount a disposable drainage bag on the body of a patientto receive draining body fluids via the stoma which extends through theouter wall of the abdomen. Appliances of this type may also be used forfistulas and all body drainage due to injuries or tumors. It is alsohighly desirable to provide an effective. airtight seal between the bodyand the bag holder shield and between the stoma and the bag holdershield to prevent the release of undesirable odors. The portion of theshield which engages the skin and stoma can cause great discomfort if itdoes not flex properly. At the same time a degree of rigidity isrequired to support the depending bag. For some patients such as thosewhich are obese a greater degree of rigidity is required to hold thebag. For other patients a greater degree of softness is required. Anumber of approaches have heretofore been used to secure a drainage bagto the body of a patient and many attempts have been made to minimizethe discomfort to the wearer and provide ease of removal and replacementof both the shield and bag. In the past a wide variety of structuralconfigurations and materials have been attempted for making up the bagholder shield but as yet they have not been entirely satisfactory forall patients. Accordingly, it is an object of this invention to providenovel and improved bag holder shields which overcome many of theabove-mentioned deficiencies in the prior art to make them suitable fora wider range of surgical appliances and patients.

Another object of this invention is to provide novel and improved bagholder shields having an improved configuration and made of moldedflexible materials which afford improved results in wearer comfort, donot irritate the skin, prevent injury to the stoma or other drainagetube of the wearer, and are highly effective in supporting of a drainagebag.

Yet another object of this invention is to provide a novel bag holdershield which is resistant to weak acids found in body secretions,resistant to oils and will not swell ordeform after extended bodycontact or cleaning with hydrocarbon solvents or the like.

Still another object of this invention is to provide a novel bag holdershield which is readily secured on the skin of the patient and may beremoved and replaced so that it may be reused many times.

SUMMARY OF THE INVENTION In accordance with the present invention in thepreferred embodiments shown there is provided a bag holder shield of asymmetrically balanced, generally oval-shaped configuration made of arelatively soft, compression-molded thermoplastic resin which has asufficient degree of rigidity to enable use by more obese patients; andin another form there is provided a shield of a similar configurationmade of a relatively soft, transfer-molded thermosetting elastomericmaterial which is suitable for more average patients and has a greaterdegree of softness. Each of these shields are in the form of an integralmember made entirely of the same flexible molded material throughouthaving a relatively thin flat base section with a smooth flatundersurface adapted to be placed over and secured to the skin andconform to the contour of the wearers body. The base section includes agenerally circular central portion and tapered end portions. Theintegral member is made to be symmetrical about both the major and minoraxes of the oval shape and terminates in generally rounded outer edges.A central flange section projects outwardly from the central portion ofthe base section and is arranged concentrically thereof to provide anarea of greatest thickness outwardly around the center of the integralmember. The flange section has a concave peripheral edge and a dishedouter face which progressively decreases in cross section toward thecenter. The center portion is formed by a relatively thin section inwhich an opening may be cut to size to receive the stoma for eachparticular patient or formed with a small opening which may be cut to alarger size. The outer end portions of the body are provided with loopsthrough which the ends of a support belt extend and are secured toprovide support for the shield on the wearer.

Other objects, advantages and capabilities of the present invention willbecome more apparent as the description proceeds taken in conjunctionwith the accompanying drawings in which:

FIG. 1 is a top plan view of one form of bag holder shield embodyingfeatures of the present invention;

FIG. 2 is an end elevation view of the bag holder shield shown in FIG.1;

FIG. 3 is a vertical sectional view of the bag holder shield taken alonglines 3-3 of FIG.'1 and further illustrated as secured to a patient andhaving a drainage bag affixed thereto and shown as having a stoma of thebody extending therethrough;

FIG. 4 is a top plan view of another form of bag holder shield embodyingfeatures of the present invention;

FIG. 5 is an end elevation view of the shield shown in FIG. 4; and

FIG. 6 is a side elevation view of the shield shown in FIG. 4.

DESCRIPTION OF PREFERRED EMBODIMENTS Referring now to the drawings, inFIGS. 1-3 there is shown one form of bag holder shield made as anintegral member 11 entirely of a compression-molded, thermoplastic resindescribed in more detail hereinafter. The shield is generallyoval-shaped and includes a relatively thin, flat base section 12 and asmooth flat undersurface 12a adapted to be placed over the body of thewearer and conform to the curvature thereof. The base section 12includes a generally circular, wider central portion 12b and a pair ofoutwardly converging ear-like narrower end portions which terminate ingenerally rounded outer edges 13. The shield is constructed to besymmetrical about both the major and minor axes of the oval shape. Theshield also includes a central flanged section 15 projecting outwardlyfrom the base section and arranged concentrically with the centerthereof to provide a bag-supporting annulus of maximum thicknesssurrounding and outwardly spaced from the center of the member. Theflanged section annulus has an overhanging lip portion 15a and a concaveperipheral edge 15b and is also shaped with a straight flat outerportion 15c parallel to the bottom surface 12a, an inwardly extendingdished outer portion 15d which converges toward the center of the memberand terminates in a flat, central portion 16 of minimum thickness. Theshield member also has an inwardly extending step 17 in the undersurfacebetween the center and outer edge of the body which further reduces thethickness of the central portion 16.

In the use of the shield a hole is cut ofa desired diameter for aparticular patient in the central portion 16 through which a stoma 18from the wearers body is passed to discharge body fluids into thesupported bag 27. The stoma is a portion of the bowel brought through anouter wall of the abdomen by the surgeon. The bag holder shield andassociated bag or pouch 27 act as an external collecting device tocollect urine or feces. The shield is also used for fistulas and allbody drains due to injuries or tumors. A U-shaped portion 19 is providedwith an outer surface of each end portion to provide a loop which theends of a support belt may extend to further secure the shield to thebody of the patient.

The shield 11 is molded as a one-piece integral unit or body made ofarelatively soft thermoplastic resin which affords a highly desirabledegree of flexibility to conform to the contour of the body and preventinjury to the stoma, adequate-rigidity and sufficient softness formaximum comfort to the wearer. The shield flexes at the ends so as to bereadily removed and reused and the annulus is sufficiently thick toafford an adequate support for the depending drainage bag. The centralportion 16 can be cut to the desired size to fit the stoma of eachindividual patient.

The typical physical properties of the shield shown in FIGS. l-3 are inthe range of about:

Durometer3244 Shore A, (38 Shore A nominal) Tensile-1440 psi-l 575 psiElongation-540-660% Tensile Modulus 0.02 X 10 psi 0.12 X psi The abovevalues are taken using the ASTM Standard No. 638.

As represented in FIG. 3, the above-described shield may be attached tothe skin 20 of a patient by first making a center aperture in portion 16through which the stoma 18 will extend and of a size so that the wallsdefining the aperture engage the sides of the stoma. A

layer of medicament such as karaya powder represented at 21 is applieddirectly to the skin 20 and a liquid seal coating is applied over themedicament which dries to form a flexible film base 22. A coat ofrubberbase adhesive is then applied to the base 22 to form an adhesivelayer 23. The undersurface of the shield 11 is precoated with the liquidseal coating to form a layer 24. The details of the liquid seal coatingand the procedure to secure the shield to the body are described in moredetail in a copending application entitled FLEXI- BLE FILM-FORMINGLIQUID AND METHOD FOR APPLYING SURGICAL APPLIANCES.

An alternative form of bag holder shield shown in FIGS. 4-6 is alsoformed as an integral or one-piece member 31 but this form is madeentirely of a thermosetting elastomeric, non-plastic, transfer-moldedflexible material. The shield includes a relatively thin, flat, flexiblebase section 32 with a smooth flat undersurface 32a to be placed overthe body of the patient and conform to the curvature thereof. The basesection includes a generally circular central portion 32b and a pair ofoutwardly converging narrower ear-like end portions 32c on each side ofthe central portion and terminate in generally rounded outer edges 33.The shield is generally oval-shaped and symmetrically balanced aboutboth the major and minor axes thereof. The shield also includes acentral flanged section 35 projecting forwardly and outwardly from thebase section and arranged concentric to the center thereof to provide abag-supporting annulus of maximum thickness surrounding and outwardlyspaced from the center thereof. The flanged section has an overhanginglip 35a and an outer concave peripheral edge 35b adapted to receive theend of the bag together with a flat outer section parallel to theundersurface and a dished outer portion 350 which inwardly convergestoward the center of the body and terminates in a flat portion 35d ofminimum thickness surrounding a central opening 36. The central openingis small enough so that it may be cut to the required stoma size. AU-shaped portion 39 is provided on the outer surface of each end portionto form a loop through which the ends of the support belt extend tofurther support the shield on the body of a wearer.

The bag holder shield 31 is secured to the patients body in the samemanner as that above described in FIGS. 1-3. The shield of thisarrangement is molded as a one-piece integral body of a materialsomewhat softer and less rigid than that of FIGS. 1 through 3 andaffords use more by patients that are not obese and require lessrigidity and greater softness. The material used for this shield is ahomogeneous blend of: (1) A polymer or polymers such as a blend ofNitrile Rubber and Polyvinyl Chloride (PVC). This blend is well suitedbecause ofits resistance to weak acids found in body secretions. It isalso very resistant to oils and will not swell or deform after extendedbody contact or cleaning with hydrocarbon solvents. (2) Inert fillerssuch as Barium Sulfate and Silica which are added to control thehardness; and (3) Organic Accelerators and sulfur used to control thetime and temperature of the molding.

The typical physical properties of the shield shown in FIGS. 4-6 are inthe range of about:

Durometer-7O Shore A Tensile-l360 psi-1660 psi Elongation540660%Modulus-775 psi-865 psi The material which exhibits thesecharacteristics and found suitable for this configuration is presentlybeing made by the US. Industrial Chemicals and identified under codeUE-636. The above described materials so far as known have notheretofore been used to provide a bag-supporting shield on the body of apatient and are therefore believed to constitute a new use thereof.

Although the present invention has been described with a certain degreeof particularity, it is understood that the present disclosure has beenmade by way of example and tha changes in details of structure may bemade without departing from the spirit thereof.

What is claimed is:

l. A drainage bag holder shield adapted to be positioned on the body ofa wearer and pass a drainage tube therethrough, said shield comprisingan integral member composed of a flexible relatively soft materialresistant to weak acids found in body secretions, resistant to oils andwhich will not deform after extended body contact, said member having athin flat base section and a relatively thick, upstanding flange sectiondiverging outwardly from the base section on the side opposite to thatside of the base adapted to contact the body of the wearer, said flangesection defining an outwardly divergent'support annulus terminating inan outer peripheral lip portion adapted to engage the open end of adrainage bag, the outer face of said flange section being concave incross-section and said flange section progressively decreasing inthickness toward the center thereof, the center thereof substantiallycorresponding in thickness to that of said base section and providedwith a hole to receive a drainage tube passing from the body of thewearer,

2. A drainage bag holder shield as set forth in claim 1 wherein saidmaterial forming the integral member is a thermoplastic resin.

3. A drainage bag holder shield as set forth in claim 1 wherein saidmaterial forming the integral member is a thermosetting elastomericmaterial exhibiting a relatively high degree of softness andflexibility.

4. A drainage bag holder as set forth in claim 3 wherein said materialincludes a blend of nitrile rubber and polyvinyl chloride.

5. A drainage bag holder shield as set forth in'claim 1 wherein theintegral member is made of a material having a durometer reading in therange of 60-70 Shore A, a tensile strength in the range of 1360 psi-1660 psi, an elongation in the range of 54 O 660 percent and a modulusin the range of775 psi865 psi.

6. A drainage bag holder shield as set forth in claim 1 wherein theintegral member is made of a material having a durometer reading in therange of 32-44 Shore A, a tensile strength in the range of 1440 psi-b1575 psi, an elongation in the range of 540-660 percent and a tensilemodulus in the range of 0.02 X psi 0.12 X10 psi.

7. A drainage bag holder shield adapted to be positioned over the bodyof a wearer thereof comprising an integral member composed of aflexible, relatively soft, molded material resistant to weak acids foundin body secretions, which is resistant to oils and will not swell ordeform after extended body contact, said member having a relativelythin, generally oval-shaped base section with a smooth flat undersurfaceadapted to be placed over the body of the wearer and conform to thecurvature thereof, said base section having a central portion and a pairof outwardly disposed ear-like end portions, a generally circular flangesection diverging outwardly from the center of said base section andarranged concentrically with the center thereof to provide a centrallydisposed, generally dish-shaped support annulus surrounding the centerof the base section, said flange section terminating in an outerperipheral lip and a peripheral groove under the lip adapted to receivean open end of a drainage bag, and the center of the member spacedoutwardly of the plane of said base section to form a recessed portionthereunder with a central opening therein sized to receive and flexiblyembrace a drainage tube from the body of the wearer,

said outer end portions having means through which the ends of a supportbelt extend to further support the shield on the wearer.

8. A drainage bag holder shield adapted to be positioned over the bodyof a wearer thereof comprising a generally oval-shaped, relatively thinflexible base section provided with a smooth flat undersurface adaptedto be placed over the body of the wearer and conform,

to the curvature thereof, said base section having a central portion anda pair of outwardly converging ear-like end portions, each said endportion terminating in a generally rounded outer edge, a relativelythick, inflexible central flange section diverging outwardly from saidcentral portion and arranged concentrically with the center of said basesection to define a centrally disposed support annulus of maximumthickness surrounding and outwardly spaced from the center thereof, saidflange section having an outer peripheral lip and a peripheral groovesurface under the lip adapted to receive an open end of a drainage bag,the outer face of said flange section being concave in crosssection andsaid flange section progressively decreasing in thickness toward thecenter thereof, the center thereof substantially corresponding inthickness to that of said base section and provided with a hole toreceive a drainage tube from the body of the wearer, said outer endportions having means for receiving the ends of a support belt tosupport the shield on the body of the wearer.

9. A drainage bag holder shield adapted to be positioned over the bodyof a wearer thereof comprising a generally oval shaped, relatively thinflexible base section provided with a smooth flat undersurface adaptedto be placed over the body of the wearer and conform to the curvaturethereof, said base section having a central portion and a pair ofoutwardly converging ear-like end portions, each said end portionterminating in a generally rounded outer edge, a relatively thick,inflexible central flange section diverging outwardly from said centralportion and arranged concentrically with the center of said base sectionto define a centrally disposed support annulus of maximum thicknesssurrounding and outwardly spaced from the center thereof, said flangesection having an outer peripheral lip and a peripheral groove surfaceunder the lip adapted to receive an open end of a drainage bag, saidflange section progressively decreasing in thickness to that of saidbase section, said central portion spaced outwardly of the plane of saidbase section to form a recessed portion thereunder with a centralopening through said central portion sized to receive and embrace adrainage tube from the body of the wearer, said outer end portionshaving generally inverted U-shaped members secured thereto for receivingthe ends of a support belt in order to support the shield on the body ofthe wearer.

22 3 I UNITED STATES PATENT OFF-ICE v CERTIFICATE OF CORRECTION PatentNo.3,762,412 Dated 2 October 1973 Inventor(s) Mathilda C. Frank It iscertified 'that error appears in the above-identified parent and thatsaid Letters Patent are hereby corrected as shown below:

In the Technical Disclosure:

Column 3, line 20, after "loop" insert through Column 4, line 57, cancel"tha" and substitute that-r- In the Claims:

Claim 6, line 132, cancel "psi-b" and substitute, psi- Sirzned andsealed this l th day of June 19714.. I

(SEAL) Attest:

EDWARD MRLETCHER,JR. C. MARSHALL DANN Attestin Officer Commissioner ofPatents

1. A drainage bag holder shield adapted to be positioned on the body ofa wearer and pass a drainage tube therethrough, said shield comprisingan integral member composed of a flexible relatively soft materialresistant to weak acids found in body secretions, resistant to oils andwhich will not deform after extended body contact, said member having athin flat base section and a relatively thick, upstanding flange sectiondiverging outwardly from the base section on the side opposite to thatside of the base adapted to contact the body of the wearer, said flangesection defining an outwardly divergent support annulus terminating inan outer peripheral lip portion adapted to engage the open end of adrainage bag, the outer face of said flange section being concave incross-section and said flange section progressively decreasing inthickness toward the center thereof, the center thereof substantiallycorresponding in thickness to that of said base section and providedwith a hole to receive a drainage tube passing from the body of thewearer.
 2. A drainage bag holder shield as set forth in claim 1 whereinsaid material forming the integral member is a thermoplastic resin.
 3. Adrainage bag holder shield as set forth in claim 1 wherein said materialforming the integral member is a thermosetting elastomeric materialexhibiting a relatively high degree of softness and flexibility.
 4. Adrainage bag holder as set forth in claim 3 wherein said materialincludes a blend of nitrile rubber and polyvinyl chloride.
 5. A drainagebag holder shield as set forth in claim 1 wherein the integral member ismade of a material having a durometer reading in the range of 60-70Shore A, a tensile strength in the range of 1360 psi-1660 psi, Anelongation in the range of 540-660 percent and a modulus in the range of775 psi-865 psi.
 6. A drainage bag holder shield as set forth in claim 1wherein the integral member is made of a material having a durometerreading in the range of 32-44 Shore A, a tensile strength in the rangeof 1440 psi-b 1575 psi, an elongation in the range of 540-660 percentand a tensile modulus in the range of 0.02 X 105 psi - 0.12 X 105 psi.7. A drainage bag holder shield adapted to be positioned over the bodyof a wearer thereof comprising an integral member composed of aflexible, relatively soft, molded material resistant to weak acids foundin body secretions, which is resistant to oils and will not swell ordeform after extended body contact, said member having a relativelythin, generally oval-shaped base section with a smooth flat undersurfaceadapted to be placed over the body of the wearer and conform to thecurvature thereof, said base section having a central portion and a pairof outwardly disposed ear-like end portions, a generally circular flangesection diverging outwardly from the center of said base section andarranged concentrically with the center thereof to provide a centrallydisposed, generally dish-shaped support annulus surrounding the centerof the base section, said flange section terminating in an outerperipheral lip and a peripheral groove under the lip adapted to receivean open end of a drainage bag, and the center of the member spacedoutwardly of the plane of said base section to form a recessed portionthereunder with a central opening therein sized to receive and flexiblyembrace a drainage tube from the body of the wearer, said outer endportions having means through which the ends of a support belt extend tofurther support the shield on the wearer.
 8. A drainage bag holdershield adapted to be positioned over the body of a wearer thereofcomprising a generally oval-shaped, relatively thin flexible basesection provided with a smooth flat undersurface adapted to be placedover the body of the wearer and conform to the curvature thereof, saidbase section having a central portion and a pair of outwardly convergingear-like end portions, each said end portion terminating in a generallyrounded outer edge, a relatively thick, inflexible central flangesection diverging outwardly from said central portion and arrangedconcentrically with the center of said base section to define acentrally disposed support annulus of maximum thickness surrounding andoutwardly spaced from the center thereof, said flange section having anouter peripheral lip and a peripheral groove surface under the lipadapted to receive an open end of a drainage bag, the outer face of saidflange section being concave in cross-section and said flange sectionprogressively decreasing in thickness toward the center thereof, thecenter thereof substantially corresponding in thickness to that of saidbase section and provided with a hole to receive a drainage tube fromthe body of the wearer, said outer end portions having means forreceiving the ends of a support belt to support the shield on the bodyof the wearer.
 9. A drainage bag holder shield adapted to be positionedover the body of a wearer thereof comprising a generally oval shaped,relatively thin flexible base section provided with a smooth flatundersurface adapted to be placed over the body of the wearer andconform to the curvature thereof, said base section having a centralportion and a pair of outwardly converging ear-like end portions, eachsaid end portion terminating in a generally rounded outer edge, arelatively thick, inflexible central flange section diverging outwardlyfrom said central portion and arranged concentrically with the center ofsaid base section to define a centrally disposed support annulus ofmaximum thickness surrounding and outwardly spaced from the centerthereof, said flange section having an outer peripheral lip and aperiPheral groove surface under the lip adapted to receive an open endof a drainage bag, said flange section progressively decreasing inthickness to that of said base section, said central portion spacedoutwardly of the plane of said base section to form a recessed portionthereunder with a central opening through said central portion sized toreceive and embrace a drainage tube from the body of the wearer, saidouter end portions having generally inverted U-shaped members securedthereto for receiving the ends of a support belt in order to support theshield on the body of the wearer.